Schneider, AlexWessjohann, Ludger A.Severi, Juliana A. [UNESP]Wagner, Vilegas [UNESP]2014-05-272014-05-272012-04-30Latin American Journal of Pharmacy, v. 31, n. 1, p. 91-96, 2012.0326-2383http://hdl.handle.net/11449/73298Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Hoffmann-La Roche Ltd., Switzerland) vs. generic (Lipiblock®, EMS-Sigma Pharma, a generic drug) were carried out with ethanol extracts of commercial samples. The generic formulation contained higher levels of common impurities as well as a considerable number of impurities not found in the reference product. The detected impurity profile of Lipiblock® revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical® appears to offer a better safety margin than Lipiblock® which, however, compares quite well to other generic formulations.91-96engGenericsHPLC-MS/MSHPLC-UVOrlistatcobesegeneric druglipiblockorsotenrotipuransuprapurtetrahydrolipstatinunclassified drugcontrolled studydrug formulationdrug impuritydrug safetydrug structurefermentationhigh performance liquid chromatographyintermethod comparisonliquid chromatographymass spectrometryArtigoAcesso restrito2-s2.0-84860125323